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Adaptix Interbody System with Titan Nanolock Surface Technology
Summary: The Adaptix Interbody System with Titan NanoLock Surface Technology is a spinal implant used in spinal fusion surgeries. It is primarily used by orthopedic surgeons and neurosurgeons to stabilize the spine and promote bone growth.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K201267 ↗
Decision Date ?
August 26, 2020
Product Code ?
MAX
Device Class ?
Class 2
Evidence ?
0 studies
The Adaptix Interbody System was cleared through the FDA 510(k) pathway on August 26, 2020. It is manufactured by Medtronic Sofamor Danek and classified as a Class 2 device under product code MAX.
What It Is
The Adaptix Interbody System is a spinal implant designed to aid in spinal fusion procedures. It features Titan NanoLock Surface Technology, which enhances bone growth and integration by providing a textured surface that encourages cellular attachment. This device is used to replace damaged or degenerated intervertebral discs, providing stability and support to the spinal column.
FDA-Cleared Indications
- Use in skeletally mature patients undergoing spinal fusion for degenerative disc disease.
- Use for reconstruction of the lumbar spine at the L2-S1 levels.
- Use in patients with symptomatic degenerative disc disease that has not responded adequately to nonsurgical treatment.
Clinical Applications
- Interbody fusion of the lumbar spine using an anterior or lateral surgical approach, as specified by the applicable implant system and technique.
- Replacement of a removed lumbar intervertebral disc space to restore disc-space height and support spinal alignment.
- Stabilization of a lumbar spinal segment while bone grows through or around the implant.
- Use with bone graft material during lumbar spinal fusion.
Practical Considerations
- The system is available in multiple footprints, heights and lordotic angles; the surgeon selects the implant based on the patient's anatomy and the operative approach.
- The implant is used with compatible surgical instruments and is typically packed with bone graft material according to the surgical plan.
- Implantation requires fluoroscopic or other intraoperative imaging to confirm level, position and alignment.
- MRI safety depends on the specific implant configuration and the conditions in the current manufacturer labeling; the implant and patient should be identified before an MRI examination.
- Contraindications and precautions include active infection, inadequate bone quality or anatomy that cannot support the implant, allergy to implant materials, and conditions that may prevent spinal fusion. The manufacturer's instructions for use should be followed.
Frequently Asked Questions
What is Adaptix Interbody System used for?
It is used in spinal fusion surgeries to stabilize the spine and promote bone growth in patients with conditions like degenerative disc disease.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons typically use this device in spinal fusion procedures.
What are the FDA-cleared indications?
The device is indicated for use in spinal fusion surgeries for conditions such as degenerative disc disease and spinal instability.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.